Prostate Cancer Antigen-3 (PCA-3) and TMPRSS2-ERG (T2-ERG) Score Changes During Initiation of Androgen Deprivation Therapy (ADT) With Triptorelin 22.5mg in Patients With Advanced Prostate Cancer (PCA): A Phase III, Single Arm Multicentre Study
- A histologically confirmed, locally advanced or metastatic prostate cancer, and naïve
to androgen deprivation therapy, and a candidate for hormonal treatment.
- An estimated survival time of at least twelve months according to the investigator's
- A performance status score ≤ 2 according to the World Health Organisation (WHO)
- Previous surgical castration.
- Previous or has planned curative prostate cancer therapy (radiation/surgery)
- Previous hormone therapy (GnRH analogues, estrogens or anti-androgens)
- Patients with risk of a serious complication in the case of tumour flare (vertebral
metastases threatening spinal cord compression or significant obstructive uropathy)
Type of Study:
Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
PCA3 score expressed as a ratio of PCA3 mRNA (messenger ribonucleic acid) over PSA (prostate specific antigen) mRNA.
Outcome Time Frame:
6 months post-treatment
Patrick Cabri, M.D.
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
- Prostate Cancer
- Locally advanced or metastatic Prostate Cancer
- Prostatic Neoplasms